Amisulpride Versus Olanzapine Treatment for Behavioral and Psychological Symptoms in Patients With Dementia of the Alzheimer Type:A Randomized, Open-label, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Changes of neuropsychiatric inventory（NPI）scores
研究概览
简要总结
Currently, olanzapine is the most widely used and studied drug for the treatment of behavioral and psychological symptoms in patients with Alzheimer's disease, but there are significant side effects. Amisulpride is a new antipsychotic that not only controls mental symptoms but also improves cognitive function. Therefore, the aim of this study was to evaluate the effectiveness and tolerability of both amisulpride and Olanzapine for treating the behavioral and psychological symptoms of dementia in patients with dementia of the Alzheimer type.
详细描述
This study was a randomized, open-label, prospective clinical study in which patients were randomized to receive amisulpride and olanzapine for 8 weeks. Drug efficacy and safety assessments were assessed at baseline, 2 weekends, 4 weekends, and 8 weekends.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •It conforms to the diagnostic standard of Alzheimer's disease in International Classification of Diseases 10th Revision (ICD-10)
- •a total score of MMSE<24
- •The patients had active behavioral symptoms with a minimum score of 20 on the 12-point Neuropsychiatric Inventory (NPI)
- •Participant or guardian has to sign informed consent. The patients' guardians will sign the informed consent on behalf of the participants when the capacity of participants to consent is compromised
排除标准
- •People with vascular dementia, frontotemporal dementia, dementia with Lewy bodies or other neurocognitive disorders;
- •Patients with severe brain organic diseases or brain trauma;
- •Physical illnesses associated with severe respiratory, circulatory, immune, and endocrine systems;
- •History of other mental disorders;
- •Those who are allergic to amisulpride or olanzapine;
- •Patients who are contraindicated with amisulpride and olanzapine: pheochromocytoma, prolactin-dependent tumors and narrow-angle glaucoma;
研究组 & 干预措施
Amisulpride group
The initial dose of amisulpride group is 50mg/d, and the maximum dose is 800mg/d.
干预措施: Amisulpride (Drug)
Olanzapine group
The initial dose of olanzapine is 2.5 mg/d, and the maximum dose is 20 mg/d.
干预措施: Olanzapine (Drug)
结局指标
主要结局
Changes of neuropsychiatric inventory（NPI）scores
时间窗: baseline, Week 2,4, and 8
The change from baseline neuropsychiatric inventory (NPI) items at week 2,4,and 8. Assess the frequency and severity of psychiatric symptoms, including delusions, hallucinations, aggression attacks, depression, anxiety, elevated emotions, indifferent emotions, de-inhibition, agitation, abnormal behaviors, sleep / night behaviors, appetite / eating disorders,the maximum scores is 144.The higher score are considered the psychiatric symptoms more serious.
次要结局
- Changes of Clinical global impression-Severity of Illness (CGI-SI) score(baseline, Week 2,4, and 8)
- Changes of Mini-Mental State Examination(MMSE) scores.(baseline, Week 2,4, and 8)
- Changes of Caregiver Burden Inventory (CBI) scores(baseline, Week 2,4, and 8)
- Treatment Emergent Symptom Scale (TESS)(Week 2,4, and 8)
- Rating scale for extrapyramidal side effects (RSESE)(baseline, Week 2,4, and 8)
- Changes of Clinical global impression- global improvement (CGI-GI)(baseline, Week 2,4, and 8)
- Abnormal Involuntary Movement Scale (AIMS)(baseline, Week 2,4, and 8)